Abstract
There are significant barriers to equitable access to cell therapies among which include the high costs of treatment, complex logistics from manufacture to bedside and the substantial economic gradients that exist between health systems of countries. Beyond the immediate issues of cost and safety balanced with efficacy, there exists a multifactorial interplay of factors which include patient and caregiver, provider and institutional, manufacturer and supply-chain, as well as regulatory or payer factors which all contribute to equity and access. With the continued evolution of advanced therapy offerings, a paradigm shift in thinking is required among policy makers, beyond the traditional drug product based regulatory frameworks and health systems. Four Key Drivers of the Paradigm shift: (1) New Manufacturing Models, (2) Technological Advancements, (3) Innovative Regulatory Approaches and (4) International Cooperation.